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Physician-scientist (MD/PhD) with > 20 years` experience in academia and industry. Hands-on experience spans from bench (experimental pharmacology) to bringing new molecules into humans, demonstrating clinical proof of concept, as well as conduct of late-stage programs up to pre-launch and market launch in multiple therapeutic areas. Academic lecturer in medicine, pharmacology, clinical development at U Frankfurt/ ZAFES, HS Fresenius, U Cardiff since 2007; appointed honorary Professor in 2010.Track record in achieving numerous efficient phase transitions (preclinical-P1 and PoC-late stage) as well as 8 approvals of new medicines in diverse therapeutic areas.Experienced Data Monitoring (DMC) Member and Chair in early and late-stage trials.Effectively worked as matrix leader, line function manager and in staff positions. Proven ability in leading teams and functions during periods of uncertainty and change coupled with strong ability to adapt to change, leading transformations and develop talent. Actively managed several change management processes to increase R&D output, spark innovation and merge and develop common cultures in and across departments and geographies (Europe, USA and Asia).Experienced in organizing, leading and moderating large events with hundreds of participants to communicate strategy, goals and foster a culture of performance and belonging.
Novartis
View- Website:
- novartis.com
- Employees:
- 79781
- Company phone:
- +41 61 324 11 11
- Company email:
- eric.althoff@novartis.com
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Global Head Safety ScienceNovartisBasel, Bs, Ch
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Global Head Safety Early DevelopmentNovartis Oct 2023 - PresentBasel, Baselstadt, Ch
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Deputy Chair Medical Safety Review Board (Msrb)Novartis Sep 2023 - PresentBasel, Baselstadt, ChIndependent, multi-disciplinary, decision board with a dedicated, proactive safety focus for all Novartis Development programs and marketed drugs.
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Chair Integrated Safety Assessment (Isa) BoardNovartis Sep 2023 - PresentBasel, Baselstadt, ChIndependently functioning, multi-disciplinary body to review and approve first in human (FIH) , pediatric clinical programs, inclusion of women of childbearing potential., suicidality assessment, cardiovascular safety monitoring across all Novartis therapeutic areas in Research and Development.
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Data Monitoring Committee (Dmc) Member And ChairNovartis 2004 - PresentBasel, Baselstadt, ChSafeguard participants safety and well-being on > 10 DMCs as Chair or Member for anti-arrhythmics, anticoagulants, anti-infectives, arthrosis, immuology and oncology and cardio-oncology. Examples:doi: 10.1016/S2665-9913(22)00044-3.doi: 10.1038/s41591-022-02059-9doi: 10.1001/jama.2021.9508
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Head Patient Safety Cardiovascularrenalmetabolism (Crm)Novartis Nov 2022 - Oct 2023Basel, Baselstadt, ChPassionate about making drug safety a science-driven analytical, proactive and predictive discipline for drug development projects as well as products in the market.CRM is one of the 5 strategic TAs in Novartis. Home of 5 key development programs with additional 2 key products (Entresto, Leqvio) on the market. Highly innovative portfolio in terms of MoA and modalities, incluing siRNAs and ASOs.
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Head Patient Safety Respiratory & AllergyNovartis Aug 2021 - Oct 2022Basel, Baselstadt, ChPassionate about making drug safety a science-driven analytical, proactive and predictive discipline for drug development projects as well as products in the market.Leading a team of physicians and scientists, accountable for medical and science-driven analyses and activities to optimize the Benefit-Risk of Novartis marketed products and development projects. Portfolio includes marketed blockbuster products (e.g. Xolair in collaboration with Roche / Genentech) and a mid- and late-stage portfolio of projects for asthma, COPD, CF, food allergies, IPF.Co-leading digitization and automation initiatives in drug safety.Co-leading data mining and analysis initiatives to identify new targets and mechanisms of drug toxicity.Data Monitoring Committee (DMC) member representing cardiovascular and thrombosis safety.
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Site Head Translational Medicine BaselNovartis 2021 - Aug 2021Basel, Baselstadt, ChManaged and lead together with functional representatives from HR, Finance, Communications, real estate and all 5 global functions (preclinical and clinical) under the Translational Medicine roof all site-related aspects, including business continuity activities during COVID.
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Therapeutic Area Head Atherosclerosis & MetabolismNovartis Jan 2019 - Aug 2021Basel, Baselstadt, ChLeading a team of physician-scientists and project leaders with responsibility for:- Early (preclinical to clinical) for Atherosclerosis, Metabolism, Obesity and all Clinical Pharmacology aspects for late stage projects portfolio affiliated with the CardioRenalMetabolism (CRM) Global Drug Development Unit.o Member of the Development Unit Leadership Team (DULT).o Member of the Disease Area Decision Board (DADB).o DMC Chair for 9 clinical projects in musculoskeletal, oncology & immunology COVID.o Late-stage projects covered by my team: Leqvio, Pelacarsen, Entresto, Canakinumab, Reasanz, Rasilez, Galvus.
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Global Head, Translational Medicine Cardiovascular & Metabolism ProfilingNovartis 2014 - Aug 2021Basel, Baselstadt, Ch• Responsible for all clinical pharmacology activities for late-stage projects affiliated with the CardioRenalMetabolism (CRM) Franchise.• Responsible, approver and company signatory for key dossier components (drug label, clinical overview, summary of clinical pharmacology, summary of pharmacokinetics etc.).• Member of the Development Unit Leadership Team (DULT). Responsibility and decision-making authority for the entire Global Drug Development portfolio of the cardiovascular, renal and metabolism late-stage indications.• Member of the Franchise Leadership Team (FLT).• Member of the Integrated Safety Assessment Board (ISAB) with decision-making authority for all First In Human trials, Women of ChildBearing Potential (WCBP), pediatric programs, ad-hoc safety reviews) for entire Novartis pharmaceuticals portfolio (including Oncology).• Member of the Integrated Scientific Review Committee (ISRC) with decision authority of all late-stage cardiovascular and metabolism clinical trials in Global Drug Development.
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Global Head, Translational Medicine Cardiovascular & Metabolism Profiling (Liver & Renal)Novartis 2017 - 2019Basel, Baselstadt, ChRole expanded in 2017 to cover in addition to cardiovascular, metabolism and liver projects also renal projects.
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Global Head, Translational Medicine Cardiovascular And Metabolism Profiling (Liver)Novartis 2015 - 2017Basel, Baselstadt, ChRole expanded in 2015 to cover in addition to cardiovascular also metabolism and liver/ NASH projects.Highlights: Obtained marketing approval for Entresto®, the first ARNI in heart failure in record time ahead of planned approval date.Reasanz®/ Serelaxin submission in AHF.Serelaxin indication expansion lead (SLT).Transitioned one NASH asset to late-stage development. Substantial contributions to dose selection for P2/3 based on biomarkers and PK/PD. Transitioned LIK066/ Licogliflozin to late-stage development. Substantial contributions to dose selection for P2/3 based on biomarkers and PK/PD.
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Member, Integrated Safety Assessment Board (Isab)Novartis 2011 - 2014Basel, Baselstadt, ChStanding member and occasionally stood in for the chair of the Integarted Safety Assessment Board with respect to entry into human (FIH), pediatric clinical programs, suicidality assessment, cardiovascular safety monitoring, studies in women of childbearing potential.
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Chair, Scientific Review CommitteeNovartis 2011 - 2014Basel, Baselstadt, Ch• Full final decsion-making authority for all clinical triasl ran out of NIBR. Reviewed and approved approx. 300 clinical protocols plus 450 amendments from all NIBR TAs.• Member and deputy-Chair of the Integrated Safety Advisory Board (ISAB) with decision authority for all First In Human trials, women of childbearing potential, pediatric programs, ad-hoc safety reviews) for entire Novartis discovery & development portfolio (including Oncology).• Re-engineered the entire review process and workflow and implemented a Novartis-specific, custom-built, web-based, document authoring and approval tool (CAT) to create Translational Medicine study protocols from scratch for clinical teams & reviewers (new process, required documentation, reviewers guidance documents, amendment metrics, IT-interface).• After successful implementation in NIBR, CAT was adapted in Novartis Global Drug Development.• Continuous feedback of lessons learned and creation of clinical standards (e.g. QT assessments, CV safety guidance document, flexible protocol writing, avoiding amendments etc.).• Member of Drug Investigative Safety Leadership Team (DIS-LT) for mechanistic safety questions in Preclinical Safety.
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Professor & Module LeaderCardiff University 2007 - PresentHighlights:• Co-created new MSc university course in International Pharmacoeconomics and Health Economics (MIPHE).• Module Leader for global Pharmaceutical Development and Regulations since 2007.• Academic supervisor/ examiner of >40 MSc/ PhD theses. -
Associate Editor, Journal Of Translational MedicineSpringer Nature 2008 - 2023Berlin, Berlin, De -
Global Head, Vp Exploratory Clinical DevelopmentTakeda Pharmaceuticals (Formerly Nycomed) 2008 - 2011Zurich, Ch• Global head with full responsibility and accountability for all translational medicine and clinical pharmacology aspects at Nycomed• Covering entire indication spectrum (respiratory, dermatology, GI, immunology).• Lead the transformation of a phase 1 Human Pharmacology department into an integrated Exploratory Clinical Development Unit (including clinical Proof of Concept).• Doubled productivity of department (no. of studies and expansion of scope) with same number of staff in less than 2 years.• Achieved 1 NDA (Daxas®), 2 sNDAs, start of 3 PoC programs, start of 4 FIM programs (HDAC, 2 PDE4s, Namilumab (MT203, anti-GM-CSF-mAb)).• Member of the Discovery & Early Development Board (DEB) with full decision-making authority from target ID to clinical proof of concept (PoC).• Chair of the Joint Steering Committee with Micromet (now Amgen) for Namilumab in rheumatology.•Lead global portfolio expansion initiative across R&D and commercial functions. •Developed complete clinical development program and business case (NPV) for portfolio in diabetes. -
Global Head, Vp Project Direction- Cardiovascular & Head Projects FrankfurtSanofi-Aventis 2005 - 2008Paris, France, Fr• Led the global Project Direction for the worldwide cardiovascular portfolio (18 projects, 4 sites (USA, France, Germany).• Portfolio included projects from preclinical to phase 4 (e.g. Lovenox®, Plavix®, Aprovel®, Co-Aprovel®, Duo-Plavin®, Xatral®, Multaq®, Aquilda®).• 5 NCE submissions, 6 sNDAs/ JNDAs, 10 phase transitions in 3 years.• Co-chair of the Joint Development Committee for Plavix® with BMS.• First gene therapy (riferminogene pecaplasmid, NV1FGF) brought into phase 3 in Europe.• Additional role as head of the German Project Direction department in the areas of diabetes, thrombosis, internal medicine and CNS (total of 13 global project directors).• Member of the Sanofi Global Development Board.• Member of the Site Management Committee Frankfurt • Lead cultural and organizational change during post-merger period with focus on integration and harmonization of cultural, methodological and process differences.• Developed department identity with associates (performance, collaboration, knowledge sharing, mutual support) KPIs: zero fluctuation, numerous internal/external applications.• Co-lead preparation of first Sanofi R&D (2007) day in the history of the company. -
Global Clinical Research Director, Global Clinical DevelopmentSanofi-Aventis 2005 - 2006Paris, France, FrHighlights:• Lead worldwide clinical phase 3 programs and global clinical team with 3 large phase 3 trials in lower urinary tract syndrome, erectyle dysfunction, prostatitis.• Started pediatric development program, obtained FDA pediatric written request, and thus 6 months patent term extension.• Lead Japanese submission for Alfuzosine/ Xatral®, obtained Japanese marketing approval.- Obtained FDA-written request for Xatral® US pediatric program and related patent term extension• Started pediatric development program, obtained FDA pediatric written request, and thus 6 months patent term extension.• Lead Japanese submission for Alfuzosine/ Xatral®, obtained Japanese marketing approval.
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Global Project Team Leader Early Clinical DevelopmentSanofi-Aventis 2002 - 2005Paris, France, FrHighlights:• Lead 4 programs and respective global teams achieving:• 2 antithrombotics in record time (<1 year) from phase 1 to clinical proof of concept and prepared via modeling and simulation and holistic data integration the dose range finding program.• Brought eNOS enhancer into man and established dedicated pharmacodynmic biomarkers for PoC.• Member of the in-licencing screening and review team• Aventis Viva award for delivery of 2 PoCs in parallel in record time.
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Clinical Pharmacologist And Phase 1 Ward PhysicianGrünenthal Group 1999 - 2002Aachen, De• Author of key dossier components (export reports, efficacy summary, safety summary) for Gatifloxacin/ Bonoq® in CAP, AECB, SSTI, sinusitis, prostatitis, UTIs.• 2 FIM programs conducted as phase 1 physician in in-house clinical pharmacology unit.• Lead clinical pharmacologist for Tapentadol (approved today as Nucynta®), a combined opioid-noradrenaline re-uptake inhibitor.• Physician in Grnenthal`s clinical pharmacology unit with medical responsibility for FIH and PD studies for own pain drugs.• Completed postgarduate training in clinical pharmacology. -
Medical ManagerRoche 1996 - 1999Switzerland 🇨🇭 , Ch• Scientific/ medical lead for 2 product launches (Posicor®, Xenical®).• Lead 5 phase 3a/b trials with Mibefradil/in hypertension and stable angina in a semi-virtual environment.• Achieved the most successful product launch of a new CV drug in the German market ever.• Trained a 200 FTE new sales force in cardiovascular disease.• Conceptualized and set up 2 phase 3a/b trails with GP2b/3a inhibitors Lamifiban and Sibrafiban in ACS.• Conducted and lead 2 phase 3b trials with Orlistat/ Xenical® in obesity which were a critical P3 safety commitment.• Qualification as PI/ "Leiter Klinische Prüfung" according to German Drug Law.
Markus Hinder Skills
Markus Hinder Education Details
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Heidelberg UniversityDoctor Of Medicine (M.D.) -
Cardiff University / Prifysgol CaerdyddGlobal Pharmaceutical Development And Regulations
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Ebs Universität Für Wirtschaft Und RechtPostgraduate Course In Health Care Management
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Goethe University FrankfurtCertificate For Genetic Counseling
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Leiden UniversityModeling & Simulation With Prof. Meindert Danhof
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The University Of FreiburgEmergency Medicine Clinical Pharmacology
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University Of BaselPharmaceutical Medicine
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Université Paris CitéCentre Hospitalier Universitaire (Chu) Bichat-Beaujon
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Université Libre De BruxellesClinical Trial Methodology And Statistics
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University Of ZurichM.D.
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Harvard Medical SchoolImmunology Certificate Of Achievement
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University Of ZurichCertified Als Provider European Resuscitation Council (Erc)
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The Royal College Of Physicians, UkUk
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German Academy For Preventive MedicinePreventive Medicine
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University Of ZurichVisiting Lecturer Medical Faculty
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Harvard Medical SchoolGenetics
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University Of St.GallenCo-Founding Member Competence Center For Pharma Innovation
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ImdManagement And Leadership Course
Frequently Asked Questions about Markus Hinder
What company does Markus Hinder work for?
Markus Hinder works for Novartis
What is Markus Hinder's role at the current company?
Markus Hinder's current role is Global Head Safety Science.
What is Markus Hinder's email address?
Markus Hinder's email address is hinderma@web.de
What schools did Markus Hinder attend?
Markus Hinder attended Heidelberg University, Cardiff University / Prifysgol Caerdydd, Ebs Universität Für Wirtschaft Und Recht, Goethe University Frankfurt, Leiden University, The University Of Freiburg, University Of Basel, Université Paris Cité, Université Libre De Bruxelles, University Of Zurich, Harvard Medical School, University Of Zurich, The Royal College Of Physicians, Uk, German Academy For Preventive Medicine, University Of Zurich, Harvard Medical School, University Of St.gallen, Imd.
What skills is Markus Hinder known for?
Markus Hinder has skills like Drug Development, Clinical Development, Translational Medicine, Clinical Trials, Clinical Pharmacology, Clinical Research, Translational Research, Pharmaceutical Industry, Pharmacology, Biomarkers, Lifesciences, Medical Affairs.
Who are Markus Hinder's colleagues?
Markus Hinder's colleagues are Astrid Manzano, Tea Bela Kočar, Bhupendra Sharma, Arabelle Pfrunder Pauli, Alex Mitchell, Venkat Reddy, Julie Dillon.
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